A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Muraglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240370

CV168-025

Details and patient eligibility

About

The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetics
HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
Fasting C-peptide ≥1.0 ng/mL
BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL

Exclusion criteria

symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study
history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.